Pain Control With Regional Anesthesia Following Pediatric Cardiac Surgery: A Randomized Double-Blinded Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Total Amount of Opioid Medications Administered
研究概览
简要总结
The purpose of this study is to evaluate pain control following pediatric cardiac surgery with the use of local anesthesia via an ultrasound guided regional anesthetic technique compared with surgeon delivered wound infiltration.
详细描述
This is a single center, randomized, double blind investigation which will compare postoperative pain control indices, functional recovery metrics and patient/parental satisfaction for pediatric patients receiving an ultrasound guided regional anesthetic versus surgeon delivered wound infiltration in children undergoing primary atrial and ventricular septal defect repairs. Surgical and anesthesia care, with the exception of the technique of local anesthetic administration, are not altered for study purposes. Subjects are randomized 1:1 to either bilateral Pecto-Intercostal Fascial Block and unilateral Rectus Sheath Block or infiltration of the wound through the perioperative period. Both interventions will use an equal volume of Ropivacaine 0.2% based on weight. Exploratory data will be collected for up to 30 days postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children less than 18 years old
- •Presenting for primary atrial septal defect or ventricular septal defect repair
- •Informed consent / assent provided
排除标准
- •Patients on opioid therapy at the time of surgery
- •History of sternotomy
- •Planned postoperative intubation
- •Current diagnosis of a chronic pain syndrome.
研究组 & 干预措施
Regional Anesthesia
Ultrasound guided blocks
干预措施: Regional Anesthesia (Procedure)
Regional Anesthesia
Ultrasound guided blocks
干预措施: Ropivacaine 0.2% Injectable Solution (Drug)
Wound Infiltration
Surgeon-delivered wound infiltration
干预措施: Wound infiltration (Procedure)
Wound Infiltration
Surgeon-delivered wound infiltration
干预措施: Ropivacaine 0.2% Injectable Solution (Drug)
结局指标
主要结局
Total Amount of Opioid Medications Administered
时间窗: Up to 12 hours after surgery
Postoperative opioid medication expressed in morphine equivalents per kilogram
次要结局
- Total Amount of Opioid Medications Administered(Up to 48 hours after surgery)
- Postoperative Pain Intensity AUC(48 hours)
